On January 29, the U.S. Food and Drug Administration or FDA alerted healthcare professionals and patients about a rare, but serious, complication in the liver reported in some HIV patients taking Videx/Videx EC didanosine. Videx/Videx EC is marketed by biopharmaceutical company Bristol-Myers Squibb Company (BMY)
Videx is an antiretroviral medicine first approved by the FDA in 1991. Videx EC is a delayed-release version of Videx approved in 2000. Videx/Videx EC is used in combination with other antiretroviral medicines to treat human immunodeficiency virus or HIV infection in children and adults.
FDA said during an 18-year period, 42 cases of non-cirrhotic portal hypertension were reported to the FDA's Adverse Event Reporting System for patients taking Videx/Videx EC.
Non-cirrhotic portal hypertension occurs when blood flow in the portal vein - a major vein in the liver - slows down and leads to severely enlarged veins in the esophagus. These enlarged veins, called esophageal varices, are thin and can break open, resulting in serious, and potentially fatal, bleeding.
Of the 42 post-marketing cases of non-cirrhotic portal hypertension in patients using didanosinetwenty-six were males, 14 were females, and in two no gender was specified. Didanosine is a prescription medication used along with other drugs to treat patients who are infected with HIV, the virus that causes AIDS. Didanosine works by reducing the growth of HIV.
Duration of didanosine treatment ranged from months to years before development of non-cirrhotic portal hypertension. There were four deaths total in the 42 reported cases due to bleeding or liver failure.
FDA said the Videx and Videx EC product labels have been revised to help ensure that health care professionals and patients are aware of the risk and the signs and symptoms of non-cirrhotic portal hypertension.
FDA's decision to revise the drug label for didanosine is based on post-marketing reports of patients developing non-cirrhotic portal hypertension while using didanosine. Because of the potential severity of portal hypertension, including death from hemorrhaging esophageal varices, FDA said it has revised the Warning and Precautions section of the didanosine drug label to assure safe use of the medication.
The FDA evaluation concluded that the clinical benefits of Videx/Videx EC in certain patients with HIV continue to outweigh potential safety risks. The decision to use this drug, however, must be made on an individual basis between the treating physician and the patient.
Videx/Videx EC does not cure HIV infection, may not prevent development of HIV-related illnesses, and may not prevent the spread of HIV to other people, FDA noted.
BMY rose $0.02 or 0.08% and closed Monday's regular trading at $24.38. After hours, BMY rose $0.21 or 0.86% and traded at $24.59.
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